GUEST COLUMNISTS

• Key Questions To Ask When Entering A Pharma Partnership

  Before entering a partnership, pharma and biotech executives need to ask themselves and their prospective partners key questions in five important areas.

• Container Closure Integrity Testing Strategies For Gene Therapies

  Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.

• Targeting Von Willebrand Factor With An RNA Aptamer To Treat Stroke

  Developing new treatments for acute ischemic stroke that can quickly and safely intervene at the right place and time has been a challenging endeavor. Today, the situation is changing due to technological developments related to stroke and recent advances in RNA-based medicines.

• Will Point-Of-Care Manufacturing Unlock The Value Of Autologous Cell Therapies?

  To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC compresses the vein-to-vein process, brings production closer to the patient, and has the potential to address other ongoing concerns, such as reduction of risks and costs.

• The Business Case For Pharmaceutical Continuous Manufacturing

  Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.

• Should My Biotech Startup Buy Or Produce The Proteins We Use?

  "Should we build out an internal group of scientific expertise or delegate work to external vendors?," is a question that this author has faced in his career. He shares key considerations building protein science teams.

• How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?

  Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.

• Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead

  Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.